FDA Inspection
Pentax of America IncPentax of America Inc – FDA Inspection, Apr 2, 2015
Record Details
This FDA Inspection record concerns Pentax of America Inc, with an inspection on April 2, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pentax of America Inc
- Inspection Date
- April 2, 2015
- Product Type
- Devices
View Company Profile
ID · ea6db0bc-d56f-48a2-b2c8-67eb44596f7f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 921077
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
Other FDA inspections of Pentax of America Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 20, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 27, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 17, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 18, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 17, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Pentax of America Inc
- FDA Inspection 1211451 - 2023-07-20
- FDA Inspection 1066901 - 2018-09-27
- FDA Inspection 906155 - 2014-12-17
- FDA Inspection 812553 - 2012-12-18
- FDA Inspection 718354 - 2011-03-17
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